Colorectal CancerE-DISTANCENCT06513481
A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery
An observational study of Colorectal Cancer, run by RenJi Hospital.
Trial summary
This project intends to conduct a multicenter, prospective, observational cohort study, aiming to explore the impact of the timing of pharmacological thromboprophylaxis initiation on postoperative bleeding risk and the effectiveness of venous thromboembolism (VTE) prevention in Chinese patients after colorectal cancer… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nardraparin calcium injection
- Type of treatment
- Injection or infusion
- How many people
- 914 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were diagnosed with colorectal cancer and underwent radical surgery (laparoscopic or open surgery) with an estimated operation time of >45 minutes. Patients with expected survival >6 months after surgery.
Who may be able to join
- 1.Age > 18 years old; 2.The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2； 3.The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was >45 minutes, and the expected postoperative survival time was >6 months.
- 4.The patient or guardian agrees to the study plan and signs the informed consent.
Who cannot join
- 1.Renal insufficiency (CrCl<30 mL/min) or hepatic insufficiency (ALT> 3 times the upper limit of normal); 2.The patient was diagnosed with colorectal cancer with a cTMN stage of cT4 and/or local unresectable lesions. Unresectable local recurrent lesions included: (1) extensive lateral pelvic wall invasion, (2) external iliac vascular involvement, (3) tumor invasion into the great sciatic notch, sciatic nerve invasion, and (4) invasion of the second sacrum level and above.
- 3.Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; 4.The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months; 5.Known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia; 6.VTE occurred within 3 months before surgery; 7.Use heparin or oral anticoagulant therapy within 5 days before surgery; 8.Women who are pregnant or breastfeeding; 9.Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery: a Multicenter, Prospective, Observational Cohort Study
This project intends to conduct a multicenter, prospective, observational cohort study, aiming to explore the impact of the timing of pharmacological thromboprophylaxis initiation on postoperative bleeding risk and the effectiveness of venous thromboembolism (VTE) prevention in Chinese patients after colorectal cancer (CRC) surgery. The research outcomes of this project could provide valuable insights for optimizing the prevention and management of VTE after CRC surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Nardraparin calcium injection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nardraparin calcium injectionDrug
The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day
Nardraparin calcium injectionDrug
The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day
| Study group | Role | What they receive |
|---|---|---|
| Early initiation of drug prophylaxis (within 24 hours after surgery) | Patients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out early initiation of drug prophylaxis (within 24 hours after surgery) Receives: Drug: Nardraparin calcium injection | |
| Late initiation of drug prophylaxis (24 hours after surgery) | Patients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out late initiation of drug prophylaxis ( 24 hours after surgery) Receives: Drug: Nardraparin calcium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE events within 28 days after surgery
Patients were followed up for VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), within 28 days after surgery. Diagnosis of DVT: The lower limb is examined based on clinical symptoms (swelling and pain in the lower limb, tenderness in the back of the lower limb and/or in the inner thigh) and/or by color ultrasound or venography. The diagnosis of PE is based on clinical findings (dyspnea and shortness of breath), laboratory tests (plasma D-dimer), and CT pulmonary angiography (CTPA). Vte events were evaluated at 7 and 28 days after surgery. If a patient develops a VTE event, the patient is treated with VTE and assessed for thrombotic progression by ultrasound in both lower limb veins after 2 weeks.
Measured: 7 and 28 days after surgery
Secondary outcomes (1)
Any bleeding event within 28 days after surgery
Patients were followed up for any bleeding events within 28 days after surgery, including major and minor bleeding events. According to the International Society of Thrombosis and Hemostasis Standards (ISTH standards). All patients were followed up at 1, 7, and 28 days after surgery through inpatient or outpatient follow-up and bleeding investigation.
Measured: 1，3，7 and 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start16 Jul 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 914 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-chun Gu, RenJi Hospital
- Investigators
- Zhi-Chun Gu, Principal investigator, Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513481
- Sponsor's protocol ID
- LY-007-B-AMD-01
- Acronym
- E-DISTANCE
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery: a Multicenter, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06513481
- Acronym / sponsor ID
- E-DISTANCE / LY-007-B-AMD-01
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 914 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 Jul 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project intends to conduct a multicenter, prospective, observational cohort study, aiming to explore the impact of the timing of pharmacological thromboprophylaxis initiation on postoperative bleeding risk and the effectiveness of venous thromboembolism (VTE) prevention in Chinese patients after colorectal cancer (CRC) surgery. The research outcomes of this project could provide valuable insights for optimizing the prevention and management of VTE after CRC surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early initiation of drug prophylaxis (within 24 hours after surgery) | – | Drug: Nardraparin calcium injectionPatients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out early initiation of drug prophylaxis (within 24 hours after surgery) |
| Late initiation of drug prophylaxis (24 hours after surgery) | – | Drug: Nardraparin calcium injectionPatients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out late initiation of drug prophylaxis ( 24 hours after surgery) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were diagnosed with colorectal cancer and underwent radical surgery (laparoscopic or open surgery) with an estimated operation time of >45 minutes. Patients with expected survival >6 months after surgery.
Key inclusion criteria (2 listed)
- 1.Age > 18 years old; 2.The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2； 3.The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was >45 minutes, and the expected postoperative survival time was >6 months.
- 4.The patient or guardian agrees to the study plan and signs the informed consent.
Key exclusion criteria (2 listed)
- 1.Renal insufficiency (CrCl<30 mL/min) or hepatic insufficiency (ALT> 3 times the upper limit of normal); 2.The patient was diagnosed with colorectal cancer with a cTMN stage of cT4 and/or local unresectable lesions. Unresectable local recurrent lesions included: (1) extensive lateral pelvic wall invasion, (2) external iliac vascular involvement, (3) tumor invasion into the great sciatic notch, sciatic nerve invasion, and (4) invasion of the second sacrum level and above.
- 3.Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; 4.The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months; 5.Known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia; 6.VTE occurred within 3 months before surgery; 7.Use heparin or oral anticoagulant therapy within 5 days before surgery; 8.Women who are pregnant or breastfeeding; 9.Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nardraparin calcium injectionThe dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day | Drug | Early initiation of drug prophylaxis (within 24 hours after surgery) |
| Nardraparin calcium injectionThe dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day | Drug | Late initiation of drug prophylaxis (24 hours after surgery) |
Primary outcome
VTE events within 28 days after surgery
Time frame: 7 and 28 days after surgery
Patients were followed up for VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), within 28 days after surgery. Diagnosis of DVT: The lower limb is examined based on clinical symptoms (swelling and pain in the lower limb, tenderness in the back of the lower limb and/or in the inner thigh) and/or by color ultrasound or venography. The diagnosis of PE is based on clinical findings (dyspnea and shortness of breath), laboratory tests (plasma D-dimer), and CT pulmonary angiography (CTPA). Vte events were evaluated at 7 and 28 days after surgery. If a patient develops a VTE event, the patient is treated with VTE and assessed for thrombotic progression by ultrasound in both lower limb veins after 2 weeks.
1 secondary outcome
Any bleeding event within 28 days after surgery
Time frame: 1，3，7 and 28 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Chun Gu principal investigator
Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Hu, PhD (+8615000090636, humeng@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE events within 28 days after surgery (time frame: 7 and 28 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.